In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-31-2016

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Systematic format of properties in the supporting
  documentation of a certified reference material
  4.1 Format of properties
  4.2 Construction of systematic designations
  4.3 Trivial names
5 Properties, production, and characterization of a
  certified reference material
  5.1 Hierarchical position
  5.2 Properties
  5.3 Production and characterization
6 Content of supporting documentation
  6.1 Supporting documentation
  6.2 Label
  6.3 Certificate
  6.4 Certification report
Annex A (informative) - Certified reference materials
        with nominal properties or ordinal quantities
Bibliography
Annex ZA (informative) - Relationship between this
         International Standard and the Essential
         Requirements of EU Directive 98/79

Describes requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511.

This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.

This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.

This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.

Committee	CH/212
DevelopmentNote	Supersedes BS EN 12287 & 07/30157023 DC. (05/2009)
DocumentType	Standard
Pages	26
PublisherName	British Standards Institution
Status	Current
Supersedes	07/30157023 DC : 0 BS EN 12287:1999

Standards	Relationship
EN ISO 15194:2009	Identical
ISO 15194:2009	Identical

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO Guide 32:1997	Calibration in analytical chemistry and use of certified reference materials
ISO 15195:2003	Laboratory medicine Requirements for reference measurement laboratories
ISO 15193:2009	In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO Guide 33:2015	Reference materials Good practice in using reference materials
ISO Guide 35:2017	Reference materials Guidance for characterization and assessment of homogeneity and stability
ISO 18153:2003	In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO/IEC Guide 63:2012	Guide to the development and inclusion of safety aspects in International Standards for medical devices
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO/IEC Guide 15:1977	ISO/IEC code of principles on "reference to standards"
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
ISO 17511:2003	In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
ISO Guide 30:2015	Reference materials Selected terms and definitions
ISO 5725-2:1994	Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO Guide 31:2015	Reference materials — Contents of certificates, labels and accompanying documentation
EN 980:2008	Symbols for use in the labelling of medical devices
ISO Guide 34:2009	General requirements for the competence of reference material producers
ISO/IEC Guide 98-3:2008	Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)

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BS EN ISO 15194:2009

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

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